Sunday, July 7, 2013

KIDNEY STORIES : DOES THE IMMUNOSUPPRESSIVE DRUG BILL CONFLICT WITH THE RECENT BACKLASH AGAINST THE CMS DECISION TO CUT FUNDING TO DIALYSIS PATIENTS



KIDNEY STORIES: DOES THE IMMUNOSUPPRESSIVE DRUG BILL CONFLICT WITH THE RECENT BACKLASH AGAINST THE CMS SUGGESTION TO CUT FUNDING TO DIALYSIS PATIENTS?
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DOES THE IMMUNOSUPPRESSIVE DRUG BILL CONFLICT WITH THE RECENT BACKLASH AGAINST THE CMS SUGGESTION TO CUT FUNDING TO DIALYSIS PATIENTS?
         
          When a patient’s kidneys fail, he has 3 choices; (1) dialysis; (2) a preemptive transplant; or (3) death.  Although there is little question that a transplant results in the best lifestyle for a patient, more often than not, dialysis is the initial course chosen.  This occurs because there is a shortage of available kidneys and donors.  Over 90% of us with End Stage Renal Disease end up starting our initial course of treatment on dialysis.  http://www.bidmc.org/Centers-and-Departments/Departments/Transplant-Institute/Kidney/The-Benefits-of-Transplant-versus-Dialysis.aspx. According to the NKF, 26 Million Americans have Chronic Kidney Disease.  415,013 ESRD patients receive dialysis at least 3 times per week to replace kidney function.  See flyer from NKF called “Kidney Disease by the Numbers.”  www.kidney.org/advocacy/…/KIDNEY_DISEASE_BY_THE_NUMBERS. Pdf.

Recently, a question was raised to me if the National Kidney Foundation prefers preserving the dialysis system over transplants.  As the Advocate for the State of Indiana for the NKF, I would say this is incorrect. 
          The NKF has proposed the End the Wait program, a bold, progressive proposal to universally lessen the wait for a transplanted kidney across the U.S. to less than a year. http://www.kidney.org/transplantation/endthewait/index.cfm.  The proposed initiative is part of a much larger legislative & social plan called the 2013-2018 Strategic Plan for the direction the NKF wants to take with legislation, education, awareness, prevention and treatment.  https://www.kidney.org/about/strategic_plan/2013/.  Part of both of those initiatives is legislation called “The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013,” (S.323 and H.R.1428). 
          This bill addresses the issue concerning Kidney transplant recipients who are eligible for Medicare due to irreversible kidney failure, but who are not Medicare-aged or Medicare-disabled, lose their Medicare three years after the transplant. This legislation would continue access to Medicare indefinitely, but would cover anti-rejection medications only. All other Medicare would end after three years for kidney recipients, as under current law.  https://secure2.convio.net/nkf/site/Advocacy?cmd=display&page=UserAction&id=115.   The Medicare End Stage Renal Disease (ESRD) program pays for dialysis or transplantation for over 600,000 kidney disease patients every year, regardless of age, and has saved millions of lives in the four decades since its enactment.  After a transplant, recipients must take immunosuppressive drugs every day for the life of the transplant; failure to do so significantly increases the risk of organ rejection.  Kidney recipients, who qualify for Medicare based on their ESRD rather than on age or other disability, lose Medicare coverage 36 months after the transplant.  However, if they remain on dialysis, they have lifetime Medicare eligibility.  Transplant recipients often have difficulty finding other coverage for their immunosuppressive drugs after Medicare coverage ends.
          Medicare spends an average of $86,316 per year for an individual who is on dialysis and $124,643 during the first year of a kidney transplant.  However, after the year of transplant, the cost is much lower at $24,612 for an individual with a functioning kidney transplant.  If the transplant fails, the patient returns to dialysis or receives another transplant, each covered again by Medicare. Notice that on a per year average, per patient, we are talking about almost a $60, 000.00/year difference. ($83, 316 - $24, 612= $58, 704).  https://nkfadvocacy.wordpress.com/immunosuppressive-drug-coverage/.
Extending immunosuppressive coverage beyond the 36-month post-transplant limit would improve outcomes and enable more kidney patients who lack adequate insurance to consider transplantation.  Most transplant recipients also have a higher quality of life, and are more likely to return to work than dialysis patients.
This is particularly necessary legislation when you consider that the average lifespan of a transplanted kidney from a living donor kidney functions, on average, 12 to 20 years (144 months to 240 months), and a deceased donor kidney from 8 to 12 years(96 months to 144 months). - See more at: http://www.bidmc.org/Centers-and-Departments/Departments/Transplant-Institute/Kidney/The-Benefits-of-Transplant-versus-Dialysis.aspx#sthash.wRrhXYBV.dpuf.  It becomes even more striking when you take into account that the average life expectancy of a dialysis patient is five and six years.  http://www.kidneyfund.org/kidney-health/kidney-basics/common-questions.html. Further complicating the issue, according to the NKF, of the 415,013 Americans currently on dialysis, as of March, 2013, 95,474 are awaiting a kidney transplant.  Last year, 16,485 Americans received a kidney transplant.  Every 10 minutes, someone is added to the transplant list, totaling about 3,000 each month.  Every day, 19 people on the list die awaiting a transplant.   Last year, 4,903 patients died while waiting for a kidney transplant. http://www.kidney.org/news/newsroom/factsheets/Organ-Donation-and-Transplantation-Stats.cfm.
As you can see, transplants and helping people pay for anti-rejection medications are a legislative priority, but by no means have they forsaken those of us on dialysis.
Proof of the NKF’s support of dialysis patients was shown earlier this week.  On Monday July 1, the Centers for Medicare & Medicaid Services (CMS) released the annual proposed rule to update Medicare payment to dialysis providers beginning January 1, 2014 and to modify the Quality Incentive Program (QIP), which reduces reimbursement to providers if they don’t meet specified quality measures. What is most notable about this year’s proposed payment rule (also known as the End-stage Renal Disease Prospective Payment System – ESRD PPS) is that in response to legislation passed by Congress, CMS proposed to cut payment to dialysis providers by 9.4 percent. https://nkfadvocacy.wordpress.com/2013/07/03/medicare-proposes-deep-cuts-for-dialysis/#more-684.
The American Taxpayer Relief Act (ATRA)(The Fiscal Cliff) of 2012 required CMS to reduce the payment rate based on the decline in the use of injectable drugs (and their oral equivalents), most notably, erythropoietin stimulating agents (ESA). While ATRA required CMS to reduce the payment rate it did not specify the amount of the reduction, but instead to factor in the decline in the use of these drugs and the current price of the drugs. The National Kidney Foundation (NKF) understands CMS is required by law to reduce the payment rate.  However, NKF is concerned about the impact that this large of a cut may have on patient care across the country.         
According to the NKF, Currently, across all dialysis providers, Medicare profit margins are only 3-4 percent (as estimated by the Medicare Payment Advisory Committee – MEDPAC). Since CMS is proposing a 9.4 percent cut to the base rate for Medicare payments, most providers will have to make considerable changes in how they operate in order to cover the most basic costs of care. NKF is concerned that some providers may not be able to withstand cuts and will have to close facilities and that many others may have to eliminate patient-focused programs, services, and benefits that improve patients’ health and quality of life. Rather than wait and see how dialysis facilities respond to the cuts, we hope that Congress and CMS will engage in a meaningful dialogue with dialysis providers, patient groups, professionals, and others involved in caring for patients to identify ways to reduce the proposed cuts while still complying with the law. https://nkfadvocacy.wordpress.com/2013/07/03/medicare-proposes-deep-cuts-for-dialysis/#more-684.
          Also included in this proposed rule are a number of changes to the Medicare ESRD Quality Incentive Program (QIP) that if finalized would impact Medicare payments in 2016. The QIP is a provider penalty program that has been in place since 2012. Dialysis facilities can receive a 0-2 percent reduction in Medicare payments for not meeting the specified quality measures. Each year CMS makes changes to the program to add, remove, or revise quality measures based on new standards of care, or the availability of new data. CMS is proposing to include five new measures that facilities will start being measured on in 2014.

These include:
◾The percentage of in-center and home dialysis patients with hypercalcemia (a serum calcium level above 10.2%)
◾The percentage of hemodialysis (including home) patients with a bloodstream infection
◾The percentage of dialysis patients that the facility states have been educated and advised on the risks, benefits and options for anemia treatment
◾A requirement to report on iron therapy for all pediatric patients
◾A requirement to report certain health related conditions that each dialysis patient has. These conditions include heart disease, hypertension, diabetes, drug and alcohol dependence, tobacco use as well as others.

If finalized, these five measures will be in addition to the six that are currently being measured. http://www.dialysisreports.org/ESRDMeasures.aspx.
The NKF reminds us that given the proposed 9.4 percent cut to dialysis payments in 2014, we note that for many facilities implementing strategies to achieve some of these quality measures may be particularly challenging. However, NKF believes quality measurement is an important way to drive improvement in the quality of care patients receive. As we continue to review the proposed regulation, we will consider the impact of the proposed changes to dialysis payment and to the QIP on patient care and provide recommendations to CMS before the agency issues a final rule. As we prepare these recommendations we will call on many of our patient and professional volunteers to weigh in as the experts. Comments are due to CMS August 30, 2013 and we will be sure to share with your our final comment letter and activities around this proposed rule. https://nkfadvocacy.wordpress.com/2013/07/03/medicare-proposes-deep-cuts-for-dialysis/#more-684.
The National Kidney fund has long been ardent supporters of dialysis patients.  This includes advocating for the protection of dialysis patient access and the quality of care dialysis patients receive in dialysis centers.  (Flyer, “Protect Dialysis Patient Access and Quality of Care,” from the National Kidney Foundation distributed at Advocacy on the Hill, March, 2013).  As the NKF notes, Over 415,000 people with end-stage renal disease receive dialysis treatments 3 or more times per week to replace kidney function and 82% are Medicare beneficiaries.  Some cuts to dialysis center funding have already taken place:
In 2011, the Centers for Medicare & Medicaid Services (CMS) implemented a bundled payment system for dialysis services and built in a 2% reduction in payment.
Sequestration will further reduce Medicare payments for dialysis by 2% on April 1, 2013.
These cuts on top of the proposed cuts suggested by the CMS may have the following results:
•         Continued cuts may deter providers from opening additional facilities at a time when the number of ESRD patients continues to rapidly grow.
•         The bundled payment system currently does not provide a separate payment for innovation and further cuts will leave little room for new advancements in patient care.
•         Cuts may result in reduced staffing hours at facilities and a greater burden on staff, which detracts from providing direct patient care.
•         In January 2013, the Medicare Payment Advisory Committee (MedPAC) finalized a recommendation to maintain the current level of funding for dialysis in 2014. The Chairman noted that the recommendation did not take into account sequestration or recent changes in law, which would reduce payment below MedPAC’s recommendation.
•         Given that the dialysis bundled payment system is still new, the MedPAC Chairman stated that payment rates should be held constant in order to fully assess the implications of the new payment system on patient care.
(Flyer, “Protect Dialysis Patient Access and Quality of Care,” from the National Kidney Foundation distributed at Advocacy on the Hill, March, 2013). 
The flyer concludes with the following statement:  “[The] NKF requests Congress protect patient access to quality dialysis care, by ensuring no further cuts to payment are made.”

          The original question for this blog was does the NKF favor dialysis patients over transplants or transplant patients over dialysis patients?  At the WDC Advocacy on the Hill Event in March, I was taught to advocate for both the extension of anti-rejection drugs for transplant patients for the rest of their lives as opposed to 36 months and to protect and preserve funding for dialysis centers and patients.  It is a very consistent position with the fact that more people whose kidneys fail initially end up on dialysis, and get transplanted kidneys at a later date.  They have a new, broad vision lowering the time on a transplant list universally in the USA to 1 years’ time within in the next decade. http://www.kidney.org/transplantation/endthewait/index.cfm; http://www.kidney.org/transplantation/endthewait/etw_recommendations.cfm.
They have a broad, progressive plan for both dialysis patients and transplanted patients that they are in the process of advocating and implementing. (2013-2018 Strategic Plan).  https://www.kidney.org/about/strategic_plan/2013/.
I can only conclude that the NKF is saying that so many people end up on dialysis (what is the rate about 90 %) while awaiting a transplant, that in order to improve the transplant conversion rate and extend life, we have to make sure that dialysis patients don’t die while they are waiting.  I see these things as congruent, not conflicting.  As your advocate, I am currently on dialysis and on 2, possibly 3 waiting lists for a transplanted kidney.  The numbers I have cited in this blog are all from the NKF concerning the number of people on dialysis (415,013); the number of people awaiting a transplant (95, 474 as of 3/8/2013); the number of people who received a transplant last year (16, 485); the cost per year, per person for dialysis ($86, 316); the cost per person, per year for anti-rejection meds for a transplanted patient after the first year ($24, 612).  The NKF clearly does not favor dialysis over transplantation; on the contrary they recognize that dialysis may very well come first and transplantation second.  A number of my fellow advocates from other states were transplanted kidney patients.  The NKF sponsored all of us equally.  It is very clear that transplantation leads to a better lifestyle.  As an Advocate, I celebrate all of my transplanted friends.  I too hope someday to be given the gift of life.  We are all on the same side of the rope, pulling in the same direction.  Kidney disease is a killer.  Dialysis and transplantation are our only real alternatives to maintain life.
 
 
 
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